Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Diabetic Gastroparesis

Treatments: Device: CGMS and insulin pump

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01030341

U01DK073974 (U.S. NIH Grant/Contract)

U01DK074008 (U.S. NIH Grant/Contract)

U01DK074008 GLUMIT-DG

U01DK073983 (U.S. NIH Grant/Contract)

U01DK074007 (U.S. NIH Grant/Contract)

U01DK073975 (U.S. NIH Grant/Contract)

U01DK074035 (U.S. NIH Grant/Contract)

U01DK073985 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis

Full description

This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 70 years old at registration
• Type 1 or Type 2 diabetes mellitus for at least 2 years
• Symptoms of gastroparesis (nausea, vomiting, early satiety, bloating, fullness, discomfort) for at least 1 year prior to registration
• Gastroparesis Cardinal Symptom Index (GCSI) score of 18
• Delayed gastric emptying on gastric scintigraphy within 1 year of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
• Hemoglobin A1c of at least 8.0% at registration regardless of current therapy. Individuals already receiving diabetes therapy via an insulin pump will be eligible for study participation if, in the opinion of the investigators, he/she may acquire additional benefit from continuous glucose monitoring that might improve glycemic control
• Normal upper endoscopy within 1 year of registration
• No clinical or imaging evidence of obstruction
• Successful mastering of use of CGMS during the run-in period

Exclusion criteria

• Prior gastric surgery including fundoplication
• Other systemic disease potentially causative of gastrointestinal symptoms
• Acute or chronic renal insufficiency with creatinine >1.5 mg/dL
• Psychiatric disease or eating disorder
• Pregnancy
• Any other condition which, in the opinion of the investigators, would impede compliance or hinder completion of the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

CGMS and insulin pump

Experimental group

Description:

Continuous glucose monitoring in conjunction with insulin pump

Treatment:

Device: CGMS and insulin pump